Thanks David..

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Long before COVID-19, the exclusion of pregnant people from clinical trials has been common for both vaccines and medications due to ethical — and potential legal liability — concerns. Researchers fear the interventions could cause harm to an unborn baby and frequently view pregnant people as vulnerable due to the complex physiology associated with pregnancy, according to the National Institute of Health Office of Research on Women’s Health.

But excluding pregnant people from research could place them and their children at even more risk, says Anne Lyerly, MD, an OB-GYN, professor of social medicine, and associate director of the Center for Bioethics at the University of North Carolina at Chapel Hill.

“Not only is research with pregnant people ethically allowable according to federal guidance and general ethical considerations, also it is ethically required as a matter of justice,” she says.

Lyerly decided to dedicate her work in bioethics toward advancing research during pregnancy after she became frustrated over the lack of data to inform treatment for her pregnant patients.

Frequently, doctors and their pregnant patients must decide how to treat serious health issues — such as cancer, diabetes, and psychiatric disorders — without much data on the safety of medications during pregnancy or the proper dosing for the pregnant body, Lyerly wrote in a viewpoint for the AAMC in 2018.

Last month, Pfizer-BioNTech announced that it had begun a clinical trial with 4,000 healthy pregnant women to test the safety and immune response of its vaccine in them and their children. The trial will compare results from the women who are vaccinated and women who are given a placebo, and it will track the infants’ outcomes until they are six months old.

The trial will last seven to 10 months, so the final results will not be available to help many of those who are currently pregnant make their decision.